IN THE last three months of 2021, as many as four out of 10 breast cancer centers failed to carry out genomic tests, capable of avoiding inappropriate chemotherapies in women with initial breast cancer, because they were without them. And still today one in 4 centers does not have the possibility to prescribe these tests free of charge for the patients who would benefit from them. This, despite the fact that the 20 million fund dedicated to the free application of these molecular analyzes uniformly throughout the territory was already released in July of last year. The reason? The length of the bureaucratic procedures at the regional level, which not everywhere have promptly followed the publication in the Official Gazette of the ministerial implementing decree. Even some of the regions that have issued specific resolutions are not using the resources pending the conclusion of the calls for tenders. Logistic difficulties and delays that are harming the patients, who receive chemotherapy even when not necessary. Furthermore, less than half (48%) of the hospitals where a breast center is located have organized a reimbursement process for genomic tests with precise rules.
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by Tiziana Moriconi
Insert genomic tests in Lea
How to unlock the situation and ensure the same opportunities for all women with breast cancer who could be candidates for the test? For 88% of the breast cancer centers in the survey, the solution is to include these analyzes in the Essential Assistance Levels: a measure considered a priority. The data emerge from the survey carried out by Senonetwork Onlus (the Breast Unit network), to which 102 centers responded, presented at the webinar ‘Genomic tests in Italy where are we?’. “The objective of the investigation – explains Lucio Fortunato, Member of the Board of Directors of Senonetwork and Director of the Breast Unit of the San Giovanni Addolorata Hospital in Rome – was to take a photograph on the availability of genomic tests in Breast Centers, on their effective use and on the terms of reimbursement. In 73% of Breast Centers the use of genomic tests was implemented in some way after the Ministerial Implementation Decree. However, a quarter of the structures still remain outside this process. Furthermore, there is an excessive heterogeneity of the tests, attributable to the different calls for tenders in the various Regions. Instead, they should be organized on the basis of criteria of scientific evidence, allowing the prescribability of tests with a high level of validation “.
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The situation in Italy
Italy has adapted only last year to the use of these molecular analyzes, consolidated in the rest of Europe for at least a decade, and is lagging behind the practices adopted in other European countries, such as Germany, the United Kingdom, Spain and Greece, and the indications contained in the most important guidelines of scientific societies. Also according to the results of the survey, only 30% of Breast Health Centers have had genomic tests available for more than 1 year, 65% for less than 6 months. “Despite the accumulated delay, even in Italy the awareness of the importance of these analyzes is developing among clinicians”, adds Rossana Berardi, member of the National Board of the Italian Association of Medical Oncology (Aiom), Professor of Medical Oncology at the ‘Polytechnic University of Marche and Director of the Oncology Clinic of Ospedali Riuniti in Ancona: “The survey shows that 89% of the Centers have a consolidated mentality of using genomic tests in post-surgical therapeutic planning”.
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Who are genomic testing for
The majority of breast cancer cases are of the luminal type, that is, it expresses estrogen receptors and not the HER2 protein. After surgery, systemic treatment involves the use of hormone therapy in cases considered to be at low risk or the addition of adjuvant chemotherapy to hormone therapy, in the presence of a high risk. In ‘intermediate’ risk luminal disease, there is often uncertainty about the most appropriate therapy. Hence the importance of genomic testing, which allows doctors to more accurately identify patients who may benefit from chemotherapy after surgery. Prescribing is the responsibility of multidisciplinary teams, as confirmed by 91% of the Centers. “41% of the managers of the Centers are partially satisfied with the application and implementation of the Decree in the individual Regions, 38% are completely satisfied, and 20% have little or no satisfaction”, underlines Fortunato.
Breast Health
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The voice of the patients
“The reduction in the use of chemotherapy involves significant economic savings, as well as a good quality of life”, concludes Rosanna D’Antona, President of Europa Donna Italia: “The persistent situation of inequality in access to tests is not acceptable. We ask that the LEA Commission take a decision as soon as possible, in favor of the thousands of women who could avoid this invasive treatment. Together with the 170 Associations that are part of our network, we continue the monitoring and solicitation action so that all Italian patients, who can take advantage of it, are finally assured this possibility of avoiding aggressive and disabling treatments “.
Image Credits: National Cancer Institute